Mass Balance Recovery, Absorption, Metabolism and Excretion of [14C]-BLU-5937

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: [14C]-BLU-5937

• Registration Number: NCT05244759
• Lead Sponsor: Bellus Health Inc. - a GSK company

Brief Summary

This is a single-centre, open-label, non-randomised, single-period, single-dose study in healthy male subjects designed to assess the mass balance recovery, PK, metabolite profile and metabolite identification of \[14C\]-BLU-5937.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-08-25
• Primary Completion: 2020-09-23
• Study Completion: 2021-03-02
• Status Verified: 2022-02
• Study First Submitted: 2022-02-11
• Study First Submitted QC: 2022-02-11
• Last Update Submitted: 2022-02-11
• Study First Posted: 2022-02-17
• Last Update Posted: 2022-02-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 6

Inclusion Criteria

• Healthy males

Exclusion Criteria

• History of clinically significant cardiovascular, renal, hepatic, chronic respiratory or gastrointestinal disease, neurological or psychiatric disorder,as judged by the investigator

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Arm 1	[14C]-BLU-5937	Single oral dose of \[14C\]-BLU-5937

Primary Outcome Measures

Name	Time	Method
Mass balance recovery of total radioactivity in all excreta after a single oral dose of [14C]-BLU-5937	168 hour	Mass balance recovery of total radioactivity in all excreta by analysing the total radioactivity and metabolic profile in blood, urine and faeces samples.

Trial Locations

Locations (1)

Quotient Sciences; 🇬🇧 Nottingham, Ruddington, United Kingdom